Medical Device Sterilization Ethylene Oxide

Ethylene oxide sterilization of medical devices at issue in light of closures and potential closures of certain facilities that use gas ethylene oxide eto to sterilize medical devices prior to their distribution and use the food and drug administration fda is concerned about the future availability of medical devices and.

Medical device sterilization ethylene oxide.

The fda is aware that the medline industries medical device ethylene oxide sterilization facility in waukegan il has been closed since december 13 2019 as was announced by the lake county. However favorable properties table 6 account for its continued widespread use. Although medical devices can be sterilized by several methods ethylene oxide is the most common method of sterilization of medical devices in the u s. For ethylene oxide sterilization two voluntary consensus standards ansi aami iso 11135 2014 and ansi aami iso 10993 7 2008 r 2012 describe how to develop validate and control ethylene oxide sterilization processes for medical devices and the acceptable levels of residual ethylene oxide and ethylene chlorohydrin left on a device after it.

While ethylene oxide sterilization is a necessary part of the manufacturing process for many medical devices there have been concerns recently about its effects on people who are exposed or. 872 two eto gas mixtures are available to replace eto chlorofluorocarbon cfc mixtures for large capacity tank supplied sterilizers. The eto carbon dioxide co 2 mixture consists of 8 5 eto and. And is a well established and scientifically.

Ethylene oxide sterilization and medical devices eto sterilization is a highly regulated process and device manufacturers hospitals and third party sterilizers must follow rigorous controls established by fda epa osha and other government agencies to protect patients workers and the environment. 1 2017 august 31. Ethylene oxide eo sterilization is the most common industrial sterilization technique for medical devices. A comparison of gamma e beam x ray and ethylene oxide technologies for the industrial sterilization of medical devices and healthcare products.

The following information although generic in nature is designed to provide basic information on the ethylene oxide sterilization process.